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PLUS ENVIRONMENTAL MONITORING UNDER COVID-19 ▪ FSMA PREVENTIVE CONTROLS ▪ COFFEE ROASTING
Volume 29 Number 1
FEBRUARY / MARCH 2022
UNDER
PRESSUREWhy the Food Supply Chain
Is Strained, and What the
Food Industry Can Do About It
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Contents
FEBRUARY / MARCH 2022 • VOLUME 29 NUMBER 1 • www.foodqualityandsafety.com
Features
16
COV E R STO R Y
UNDER
PRESSURE
WHY THE FOOD SUPPLY CHAIN
IS STRAINED, AND WHAT THE
FOOD INDUSTRY CAN DO ABOUT IT
BY KAREN APPOLD
© 2017 PHIVE IMAGING STUDIO - STOCK.ADOBE.COM
Safety & Sanitation Quality
21 29
Environmental Monitoring Java Jive
Under COVID-19 How to achieve quality
and safety in coffee roasting
Four ways the pandemic has changed EMPs
COVER: ©ZFFOTO / IIIERLOK_XOLMS - STOCK.ADOBE.COM
BY JASON SANDERS
for the better
AND STEPHAN RUEEGG
BY MARGARET VIETH
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February / March 2022 3
Contents
(Continued from p. 3)
Safety & Sanitation Manufacturing & Cannabis Corner
22 INDUSTRIAL FREEZING Distribution 12 CANNABIS “FLAVOR”
What food manufacturers should 34 FIRST-IN-FIRST-OUT SYSTEMS IN EDIBLES
look for in freezing equipment Enhance your inventory system Cannabis can be a tough flavor
BY DAVID HALLIFAX with the IoT to keep food safe to mask in edibles. We talked to
several producers about what
BY BRIAN RUHAAK consumers want, and how to best
meet demand
Food Service & Retail BY JESSE STANIFORTH
36 THE COTTAGE FOOD INDUSTRY
More state-level legislation is
allowing for more home-based
foods—how safe are they?
24 SUSTAINABLE POULTRY
BY MARY BETH NIERENGARTEN
PROCESSING
Four ways to save water and
chemicals
Departments
BY BOB OGREN
Quality 6 FROM THE EDITOR
26 THE CHALLENGES
OF SALT REDUCTION 7 NEWS & NOTES
How to protect your product’s 39 NEW PRODUCTS
C0lumns
taste, quality, and shelf life while
preserving food safety under 41 ADVERTISER DIRECTORY
the new FDA reduced sodium 41 EVENTS
guidance
BY JOY VIMALARAJAH
Washington Report 42 SCIENTIFIC FINDINGS
8 FDA’S WHOLE GENOME
SEQUENCING NETWORK
In The Lab A new study evaluates the costs Food Quality & Safety
32 HONEY FINGERPRINTING and benefits of the program magazine welcomes letters
Ensure honey purity through BY MARY BETH NIERENGARTEN to the editor on any relevant
mass spectrometry industry topic.
BY STÉPHANE BAYEN, PHD
Legal Update Letters should be no longer
than 350 words.
10 FSMA PREVENTIVE CONTROLS
Submit letters to:
FINAL RULE ENFORCEMENT
Samara E. Kuehne
While the rule is here to stay, Professional Editor
how is FDA judging compliance? Email: skuehne@wiley.com ©JCHIZHE / TEATIAN / EVGENIY / SERHII SHLEIHEL- STOCK.ADOBE.COM
BY SHAWN K. STEVENS, ESQ. (Letters may be edited for space
AND ELIZABETH PRESNELL and style.)
Visit us online! Other articles available at www.FoodQualityandSafety.com include:
• Hygiene Inspections: Creating • How Advances in Food Testing
A Healthy Sanitation Culture Technology Help Fight COVID-19
• Omicron Surge Slows U.S. Meat • New Food Packaging Material May
Production Kill Harmful Microbes
facebook.com/FoodQualityandSafety @FQSmag
4 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.com
2022 Call for Entries 2022 Annual Food Quality & Safety Award Is your company a food processor, service or retailer? Do you uphold the highest food standards supported by quantifiable results? This prestigious award honors the dedication and achievement of a food quality and safety assurance team that has made exceptional contributions to their company’s commitment in supplying safe food products. Add your company to the mix. Learn more at foodqualityandsafety.com/award
From The Editor PUBLISHING DIRECTOR
SENIOR ACCOUNT MANAGER
Heiko Baumgartner, hbaumgar@wiley.com
Joe Tomaszewski, jtomaszews@wiley.com
PROFESSIONAL EDITOR Samara E. Kuehne, skuehne@wiley.com
DESIGN Maria Ender, mender@wiley.com
PRODUCTION Claudia Vogel, cvogel@wiley.com
Jörg Stenger, jstenger@wiley.com
The State of Food Safety in 2022 Elli Palzer, palzer@wiley.com
T
EXECUTIVE INDUSTRY EDITOR Patricia A. Wester, trish@pawesta.com
he beginning of 2022 brings INDUSTRY EDITOR, PROJECTS Purnendu C. Vasavada, PhD,
renewed hope to the world purnendu.c.vasavada@uwrf.edu
and, in particular, to the
Advertising Director
food safety community. It
Dan Nicholas
looks as if things will return to a more 111 River Street, Hoboken, NJ 07030
normal routine and, as such, this (716) 587-2181, dnicholas@wiley.com
seems a fitting place to start my first Sales Office
column as the new Executive Indus- U.S./Canada/International
Joe Tomaszewski
try Editor for Food Quality & Safety. (908) 514-0776
As cases from the Omicron variant be- jtomaszews@wiley.com
gin to dwindle across the U.S., there’s Editorial Office
hope that this will be one of the last major waves of the pandemic. 111 River Street, Hoboken, NJ 07030-5774, USA
And there is my hope that, as we begin rebuilding the foundations Reprints: E-mail dsurdel@wiley.com
of our food safety systems, we can do far more than return to what
was before, and instead build what “should be.”
Since early 2020, food safety has been operating somewhat on Editorial Advisory Panel
autopilot. Inspections have been limited to those for cause, and
third-party audits have suffered seriously due to travel limitations. John N. Butts, PhD Hasmukh Patel, PhD
Founder and President, VP of Research and
Training events have fallen off as well. Early on, COVID-19 spread FoodSafetyByDesign, LLC; Development,
Advisor to CEO, Land O’Frost Whitehall Specialties
rapidly in food manufacturing plants, most notably among the
workers in the meat industry. Food safety teams struggled to assess Cliff Coles Mary Ann Platt
President, Clifford M. Coles
these new risks and implement the unfamiliar measures designed Food Safety Consulting, Inc.
President,
CNS/FoodSafe and RQA, Inc.
to manage transmission in their densely packed production envi-
ronments. We all learned the new language of the pandemic. Virginia Deibel, PhD Manpreet Singh, PhD
Chief Scientific Officer, Professor,
Now, ever-pressing production demands are yet another issue Deibel Laboratories Dept. of Poultry Science,
contributing to the problem. Line workers are in high demand but University of Georgia
James Dickson, PhD
always scarce, and trained employees were hard to come by even Professor, Shawn K. Stevens
before the pandemic. Fortunately, the bulk of the required PCQI Department of Animal Science, Food Industry Attorney,
Iowa State University Food Industry Counsel, LLC
classes were completed prior to the pandemic, but in-person meet-
ings and travel are still real challenges to maintaining professional Steven Gendel, PhD
Richard Stier
Senior Director,
development needs. Supply chain interruptions are also wreaking Food Science, Food Industry Consultant
havoc. Food Chemicals Codex at USP
Steven Wilson
Before the pandemic, food safety folks were tired, often under- Vijay K. Juneja, PhD Director of Seafood Commerce
Lead Scientist, and Certification,
trained, and in short supply. Now, after nearly two years, they are in Predictive Microbiology for Food Safety, Office of International Affairs
the same situation as frontline healthcare workers: burned out and USDA-Agricultural Research Service and Seafood Inspection
perhaps even more short staffed than ever. This is the landscape
facing the food safety sector in 2022. As we contemplate this return
to normal, we should look hard at this “normal” we want so badly.
What is it? Perhaps there are better ways to achieve these goals? Printed in the United States by Dartmouth Printing, Hanover, NH.
Copyright 2022 Wiley Periodicals, Inc., a Wiley Company. All rights reserved. No part
Perhaps there are new goals to achieve? I think there are both, and of this publication may be reproduced in any form or by any means, except as permitted
I’ll explore these ideas in this column in upcoming issues. under Sections 107 or 108 of the 1976 United States Copyright Act, without either the prior
written permission of the publisher, or authorization through the Copyright Clearance
Hopefully, this is the beginning of a national and interna- Center, 222 Rosewood Drive, Danvers, MA 01923: (978) 750-8400: fax (978) 750-4470.
tional dialogue on food safety, and I want to encourage everyone All materials published, including but not limited to original research, clinical notes,
editorials, reviews, reports, letters, and book reviews represent the opinions and views of
to participate in the discussion. Tell me, what bothers you most the authors and do not reflect any official policy or medical opinion of the institutions with
today? What are the most significant challenges you face? What which the authors are affiliated or of the publisher unless this is clearly specified. Materials
are your top five food safety concerns? And, most of all, how can published herein are intended to further general scientific research, understanding, and
discussion only and are not intended and should not be relied upon as recommending or
Food Quality & Safety better serve your food safety needs? promoting a specific method, diagnosis or treatment by physicians for any particular patient.
Please share your ideas and concerns with me at trish@ While the editors and publisher believe that the specifications and usage of equipment
and devices as set forth herein are in accord with current recommendations and practice
pawesta.com. Let’s really kickstart 2022! at the time of publication, they accept no legal responsibility for any errors or omissions,
and make no warranty, express or implied, with respect to material contained herein.
Patricia A. Wester Publication of an advertisement or other discussions of products in this publication should
Executive Industry Editor not be construed as an endorsement of the products or the manufacturers’ claims. Readers
are encouraged to contact the manufacturers with any questions about the features or
limitations of the products mentioned.
6 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.com
NEWS & NOTES
required provisions of the FDA Food Safety Lead author Jennifer L. Pomeranz, MPH,
Modernization Act, Produce Safety Rule, and assistant professor in the department of
good agricultural practices. public health policy and management at
Another recommendation is for the CEA New York University, fell upon the genesis
operators to implement procedures that are of the paper by accident, and says that she
effective in rapidly cooling and cold holding was looking for food labels of products for a
harvested leafy greens after harvest and different study, and searched online retailers
verify the effectiveness of the cooling and to find them. “I noticed that the labels I found
FDA Issues Recommendations cold holding procedures, including the rou- were inconsistent across retailers and some-
for Increased Food Safety at Indoor tine monitoring of processing and storage times were mock-ups of the products rather
Farming Facilities environments and product temperatures to than the real food packaging you’d find in the
prevent pathogen growth in harvested leafy store,” she tells Food Quality & Safety.
BY KEITH LORIA
greens, the agency spokesperson adds. The study examined whether 10 popular
FDA has released a report on its investigation If employing tools such as pre-harvest products across nine national online food re-
of the Salmonella Typhimurium outbreak and post-harvest sampling and testing of tailers disclosed the information panel, which
that caused 31 reported illnesses and four food, water, and the physical environment, includes the nutrition facts label, ingredient
hospitalizations in the U.S. between June growers will need to seek to identify and in- list, common allergens, and the percentage of
and August 2021. Although a conclusive root form sampling plans, limits of detection, and juice for fruit drinks. The investigators discov-
cause was not identified, based on its find- mitigation measures that control potential ered that the required information was pres-
ings, FDA has issued recommendations for sources and routes of bacterial contamination ent, visible, and legible for only 36% of the
the indoor farming community to help iden- in the growing and harvesting environment. products. What’s more, potential allergens
tify and control conditions and practices that Pond water is another challenge that were only disclosed on 11% of the items. Fail-
could result in contamination. impacts indoor farming, and the recommen- ure to disclose this information may present
The requirements and recommendations dations include ensuing that all water is safe safety concerns for consumers who depend
provided are just a few examples to remind and of adequate sanitary quality for any wa- on the labeling, as in the case of allergens,
indoor farming operators that controlled ter treatment involved. sodium, or sugar, the researchers noted.
environment agriculture (CEA) is increasing “Although, arguably, the FDA’s regula-
globally, and all types of food production tions for food labeling already apply to online
must continue to address basic food safety food retailers, the FDA has not issued a clear
concerns, including potential sources and statement confirming this to be the case,”
routes of contamination. Pomeranz says.
One of the key recommendations is for The team also conducted legal research
indoor farmers to develop a strong under- using LexisNexis to analyze federal regula-
standing of potential sources and routes of tory agencies’ authority. The researchers be-
contamination for their product, including lieve online food retailers should voluntarily
the raw materials and inputs used, as well as disclose the full information panel conspic-
possible sources of contamination through- Study: Online Food Retailers uously and legibly. “The FDA could issue
out their operations. Don’t Always Adhere to Labeling guidance documents explaining that their la-
A spokesperson for FDA tells Food Qual- Regulations beling requirements apply in the online food
ity & Safety that another recommendation is retail environment,” Pomeranz says. “Con-
BY KEITH LORIA
for growers to implement effective sanitation gress could pass a law requiring the same.
©MANGPOR2004/ PRESSMASTER - STOCK.ADOBE.COM
procedures and sampling plans, while pay- Online food retailers do not regularly pres- The USDA could also issue regulations re-
ing strict attention to hygienic operations and ent nutrition information on their websites, quiring that online SNAP [Supplemental Nu-
equipment design to ensure that cleaning and laws requiring them to do so are lagging trition Assistance Program] retailers disclose
procedures don’t contribute to the disper- behind the rules and regulations that brick- the full information panel conspicuously and
sion of any microbial contaminants that may and-mortar retailers must follow, according legibly. We hope our study will bring to light
be present. Additionally, FDA plans to assess to a new study conducted by the New York the issues consumers face when shopping
growing operations to ensure implementa- University School of Global Public Health and online and urge the federal agencies to act
tion of appropriate science- and risk-based the Friedman School of Nutrition Science and to protect consumers and ensure an efficient
preventive measures, including applicable Policy at Tufts University. and transparent marketplace.”
February / March 2022 7
Washington Report
see as sporadic—which research shows is
about 95% of foodborne infections—are,
in fact, part of an outbreak,” says Brad
Brown, PhD, senior scientific advisor for
FDA’s Center for Food Safety and Applied
Nutrition (CFSAN), adding that the im-
provements seen with WGS technology
can help detect more outbreaks through
small clusters, thereby informing both
how to respond to an outbreak and how to
prevent one.
Data support the improvements al-
ready seen with the NCBI PD program
and its component, the GenomeTrakr
network. A study conducted by Dr. Brown
and some of his colleagues at the CFSAN
and published in PLOS ONE, performed an
economic analysis of the program and con-
cluded that the NCBI PD portal has been
successful in reducing the number of total
illnesses due to WGS source tracking, and
projects the overall cost-effectiveness of
the program over time.
A Faster Way to Detect and Stop
Foodborne Outbreaks
To examine the benefits and costs of the
WGS NCBI PD program to date, Dr. Brown
and his team used an economic model
to estimate the reduction in foodborne
illnesses from three common pathogens
(Listeria, Salmonella, and E. coli) by using
FDA’s Whole Genome WSG tracking. Estimates from the model
were tested against empirical data. A fi-
Sequencing Network nal analysis was conducted to assess the
benefits and costs of implementing the
program.
A new study evaluates the costs and benefits of the program The study estimated that. by 2019, the
BY MARY BETH NIERENGARTEN WGS tracking program had effectively
helped reduce the number of people who
S
got sick from foodborne illnesses to 210 ill-
ince 2012, FDA’s GenomeTrakr the network, currently comprising more nesses annually (13% reduction) for Liste-
Whole Genome Sequencing than 50 national and international labo- ria, the most heavily sequenced pathogen
(WGS) Network has compiled a ratories that contribute to the database, tracked by the program to date, to 19,800
database that contains the ge- will grow to include more public and pri- illnesses annually (1.5% reduction) for Sal-
©AURIELAKI- STOCK.ADOBE.COM
nomes of a number of foodborne patho- vate laboratories to further speed up the monella, a relatively less sequenced patho-
gens, accessible to public and private sequencing of pathogens. gen; a 6% reduction in E. coli illnesses was
entities via the National Center for Bio- “We anticipate that WGS will help also achieved.
technology Information Pathogen Detec- us identify the true scope of outbreaks, According to Dr. Brown, lead author of
tion (NCBI PD) web portal. It is hoped that making clear that some illnesses we now the study, even accounting for uncertainty
8 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.com
in the model used to estimate these num- Other benefits to industry, he adds, The WGS program has
bers, the total burden of illness reduction, include using the database to monitor in-
or gross estimated benefit of the program, gredient supplies and to develop new rapid
generated a return on
was nearly $150 to $500 million in 2019. method and culture independent tests, as investment of as much
This represents between 0.5% and 1.5% of well as an effective tool for preventive and as $10 in averted human
the total burden of illness caused by food sanitary controls. Additionally, industry
regulated by FDA, he says. can use the database “to determine the
health costs for every $1
“The study provides strong evidence persistence of pathogens in the environ- invested in the program.
for significant improvement in food safety ment, to monitor emerging pathogens, —Travis Minor, PhD
anywhere WGS source tracking is imple- and as a possible indicator of antimicrobial
mented,” says Marc Allard, PhD, a research resistance,” he says.
microbiologist with CFSAN and coauthor
of the study. Sound Investment of human, animal, and plant pathogens,”
Renato Hohl Orsi, PhD, a senior re- Using a model to generate an estimate of says Dr. Allard.
search associate in the department of food the annual benefits and costs of the WGS The importance of this global sharing
science at Cornell University in Ithaca, N.Y., NCBI PD program to date, the PLOS ONE of pathogen surveillance is underscored
underscored the extreme value of the pro- study investigators found that the upfront by the significant value that WGS source
gram and expects that it will generate even investment dollars needed to establish tracking has had in the battle against
better results in the coming years as more the program and maintain it are easily COVID-19, he adds. He also emphasizes
isolates are added to the database. predicted to be offset by large gains from that the benefits of the program apply to
Dr. Orsi also pointed to the range of averting human health costs. When fac- the full range of infectious disease con-
benefits offered by WSG data, such as toring in lab set-up costs, collection and trol agents, such as in hospitals, nursing
testing costs, and internal costs to run the homes, medical manufacturing, waste
program, the study found that the program management, composting, agricultural
The study provides costs approximately $21.3 million per year water use, and reuse.
to run. Dr. Orsi adds that adoption of WGS
strong evidence for By 2019, the estimated net benefits of source tracking by other countries is crit-
significant improvement the program were approximately $475 mil- ical for an increasingly international food
in food safety anywhere lion, with conservative estimates at nearly supply. Particularly important is the use of
$125 million. “The WGS program has gen- WGS in countries that produce and supply
WGS source tracking is erated a return on investment of as much ingredients. “For example, a country that
implemented. as $10 in averted human health costs for uses ingredients from different suppliers in
—Marc Allard , PhD every $1 invested in the program,” says different countries could use WGS data to
Travis Minor, PhD, senior policy advisor for investigate a pathogenic isolate found in its
the CFSAN and also a coauthor of the study. final product by comparing these isolates
Their research found that the program against the database,” he says. “If the da-
specific information on isolates (e.g., the was likely cost effective in its second year tabase is thorough, the chances of finding
presence of antimicrobial resistance gene, of implementation. “These estimated ben- a match to a closely related isolate in the
serotypes for some pathogens such as Sal- efits of the WGS source tracking program database increases and can indicate from
monella, and the presence of certain viru- easily outweigh the estimated implemen- which of the suppliers or countries the iso-
lence genes), as well as the ability to better tation costs after the second year,” says Dr. late originated from.”
differentiate isolates to identify any that Brown. “Once the program is fully imple- Currently, members of the program in-
are closely related genetically, which can mented, we may see net benefits measure clude the Centers for Disease Control and
help to identify the source of an outbreak in billions of dollars.” Prevention and USDA’s Food Safety and
during an outbreak investigation. Inspection Service, as well as some U.S.
A key benefit for industry is that the Going Forward state departments of health and agricul-
NCBI PD portal’s database is available for The researchers expect that the applica- ture. Internationally, several large labora-
public access. “This can benefit the food tions of WGS source tracking will expand tories, such as Public Health England, are
industry as a whole to improve their own rapidly, and adoption of WGS surveillance planning to conduct surveillance.
safety processes and investigations,” he globally will facilitate a greater capacity For more information about the
adds. for public and private entities to detect, GenomeTrakr Network and a list of all the
Dr. Allard emphasizes that the food track, conduct root cause analysis of, and current contributing laboratories, visit
industry can use the publicly available potentially predict future pandemics, out- FDA.gov/food and click on “science and
genomic data for real-time comparison breaks, and contamination events. “We research” in the menu bar. ■
and analysis. “This can speed foodborne envision a global food shield and patho-
illness outbreak investigations and reduce gen surveillance system with many coun- Nierengarten is a freelance science writer based in Minne-
foodborne illnesses and deaths,” he says. tries sequencing and sharing the genomes sota. Reach her at mbeth@mnmedcom.com.
February / March 2022 9
Legal Update
required companies to develop written
monitoring procedures, verification pro-
cedures, and corrective action procedures
(in the event of a deviation or failure), as
well as a written supply chain program
and written recall plan.
In addition to requiring companies to
develop written food safety plans, FSMA
also established a mandated inspection
frequency that is based on overall risk for
food facilities and the specific products
they manufacture (FSMA, 124 Stat. 3885,
Sec. 201). Pursuant to the mandated in-
spection frequency, FDA is now required
to inspect domestic food facilities at least
every five years for non-high-risk facilities
and at least every three years for high-risk
facilities. With that said, in many cases,
processors will find that the inspections
are actually more frequent than the man-
dated minimums.
Initially, from an enforcement stand-
point, FDA stated that the agency’s pri-
mary focus would be on education and
technical assistance. More recently, how-
ever, now that the final rule has been in
place for almost five years, the agency has
stated it will begin taking a more aggres-
FSMA Preventive Controls sive enforcement approach, focusing less
on education and more on compliance and
Final Rule Enforcement enforcement.
In October 2020, FDA issued guidance
that provides direction to FDA inspectors
While the rule is here to stay, how is FDA judging compliance?
who are conducting assessments under
BY SHAWN K. STEVENS, ESQ., AND ELIZABETH PRESNELL the Final Rule (See Compliance Program
Guidance (CPG) Manual 7303.040. FDA
B
confirmed that high-risk facilities will be
elieve it or not, it’s been 10 years nearly all FDA-regulated facilities to de- prioritized for inspections, and inspec-
since President Obama signed velop a written food safety plan designed tors are directed to select the highest-risk
the Food Safety Modernization to ensure that the risks associated with food or process within the facility for re-
Act (FSMA) into law. In the years the production of certain food products view during the inspection to target FDA
that followed, FDA worked tirelessly to were identified and addressed. The rule resources on the most significant risks
draft enabling regulations to help facilitate required food companies to conduct a present. The CPG directs inspectors to use
©DANIEL BERKMANN- STOCK.ADOBE.COM
the congressional goals of making the U.S. hazard analysis designed to identify those FDA Form 483 as the primary, though not
food supply safer. One of the new FSMA hazards that were reasonably likely to oc- exclusive, method of agency follow-up
rules developed by FDA was the Final Rule cur in the food at issue, to identify effective for critical and major preventive controls
for Preventive Controls for Human Food. controls to eliminate or reduce any such violations that are identified. The goal of
The final rule, which went into effect hazards, and to effectively implement FDA’s Form 483’s inspection and enforce-
in 2016 and required compliance from those controls to accomplish the stated ment methodology as identified in the
all covered facilities in 2018, called for goals (see 21 C.F.R. § 117.16). The rule also CPG is “to obtain high rates of industry
10 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comcompliance,” while, at the same time, tory written food safety plan as required includes appropriate controls, adequate
encouraging voluntary corrective actions. by the final rule. The facility had, report- monitoring and verification procedures,
When a facility violates FDA regula- edly, not conducted a hazard analysis for and contains action procedures for when
tions, FDA considers those violations to the foods it manufactured (to include bio- violations do occur.
be very serious and, if they not corrected logical and allergen hazards) and had not 2. Address all potential vehicles
immediately by the facility under scrutiny, implemented sufficient preventive controls of microbiological and pathogenic
FDA can and will issue warning letters to for those hazards reasonably likely to oc- contamination. Be sure to specifically
the offending company. An FDA warning cur in the products at issue. The agency consider and evaluate all ingredient and
letter is the mechanism the agency uses to also stated that the company had failed to environmental pathogens in your food
threaten the removal of a food company’s implement appropriate monitoring proce- safety plan. Notably, each of the above
registration (in essence, threatening to dures, verification procedures, and correc- warning letters included a specific indica-
shut the company down) for uncorrected tive action procedures as required by the tion by FDA that the food safety plan did
food safety violations that the agency final rule. Although the facility responded not include a sufficient evaluation of en-
deems to be very serious. While the issu- to FDA’s initial Form 483, the agency was vironmental pathogens. These are known
ance of an FDA Form 483 to a company is not satisfied with the company’s response hazards and, when a ready-to-eat product
not widely publicized by the agency, FDA and, in November 2021, elevated its en- is exposed to the environment post-lethal-
warning letters get much more attention forcement approach from the FDA Form ity, the agency will expect to see an envi-
and are, thus, more “public.” Therefore, 483 to a warning letter. ronmental monitoring plan that includes
warning letters should be avoided at all More recently, on December 1, 2021, a written assessment of the hazards as well
costs. FDA issued Sabra Dipping Company a as appropriate controls.
We examine three recent warning let- warning letter because the facility’s food 3. Immediately perform and doc-
ters identifying instances where FDA has safety plan reportedly did not “appropri- ument corrective actions in response
found violations of the Preventive Controls ately identify and evaluate known or rea- to any FDA observation. A timely and
Final Rule. sonably foreseeable hazards” as required thorough response to any observations re-
by the final rule. Specifically, as reported corded by FDA in a Form 483 may prevent
The Warning Letters by FDA, although Sabra had created a the issuance of a warning letter. When FDA
On October 25, 2021, Maribel’s Sweets (a written food safety plan, which did in fact receives satisfactory corrective actions to
company that manufactures ready-to-eat identify certain hazards, the written plan observations, warning letters are typically
chocolate products) was issued a warning did not clearly identify whether or to what unnecessary.
letter because the facility did not have a extent those hazards required a corre- When an FDA inspector visits a facil-
written food safety plan, as required by sponding preventive control. Additionally, ity that does not have a written food safety
the Preventive Controls Final Rule. The the food safety plan, according to FDA, did plan or the controls identified in a food
facility had not completed a hazard anal- not specifically address the hazard posed safety plan are inadequate to ensure public
ysis as required by the final rule and, thus, by Salmonella on certain incoming ingredi- health, the inspector must classify the in-
failed to consider any allergen, biological, ents where Salmonella has been a hazard spection as “official action indicated” (OAI)
and mycotoxin hazards that were known known to occur. Here, too, presumably not according to the CPG. Facilities that have
or reasonably likely to occur in the ingre- satisfied with Sabra’s initial response, FDA received a classification of OAI are also
dients and products at issue. issued a warning letter. prioritized for future inspections because
According to the letter, in addition to the facility is then defined as high risk by
failing to complete a satisfactory hazard Compliance Lessons the CPG.
analysis, the company also failed to im- Important lessons can be taken from the By ensuring that your facility has a
plement needed controls for those hazards more recent waning letters issued by FDA. thorough, documented, and satisfactory
that were foreseeable or likely to occur. The For those companies looking to ensure that food safety plan that considers all poten-
company was initially issued an FDA Form they will be deemed by FDA to be in com- tial hazards and implements appropriate
483 following an FDA inspection in June pliance following their next inspection, it preventive controls, you can avoid the
2021, and although Maribel’s responded will be important to do the following: discomfort and pain of an FDA warning
to the FDA Form 483 stating that it was in 1. Create, document, and imple- letter, and focus instead on producing a
the process of creating and implementing ment a satisfactory written food safety high quality, safe, and wholesome product
a food safety plan, the company failed to plan that addresses each required el- for your customers. Indeed, keeping FDA
provide a timeline that included a date by ement. When FDA arrives for the next happy will keep each of your customers
which the written food safety plan would inspection, the agency will conduct an (and consumers) happy as well. ■
be completed and, as a result, FDA issued independent hazard analysis and risk as-
the October 25th warning letter. sessment for your process. Take steps now Stevens is a food industry attorney and founder of Food
Industry Counsel, LLC and a member of the Food Quality
Only a month later, on November 22, to ensure that your food safety plan con- & Safety Editorial Advisory Panel. Reach him at stevens@
2021, FDA issued Sarita’s Tortilla Factory a tains a thorough evaluation of all potential foodindustrycounsel.com. Presnell is the newest member of
Food Industry Counsel and has worked in the food industry
warning letter because the company had, hazards (regardless of whether or not a pre- for nearly a decade. Reach her at presnell@foodindustry
similarly, not yet implemented a satisfac- ventive control is deemed necessary), and counsel.com.
February / March 2022 11Cannabis Corner
Cannabis “Flavor” in Edibles add cannabis or cannabinoids to their
products. Should they mask it? Should
they lean into it? What do consumers
Cannabis can be a tough flavor to mask in edibles. We talked want?
to several producers about what consumers want, and how to Wright opened his first company after
best meet demand the 2015 Supreme Court of Canada deci-
sion that the production and distribution
BY JESSE STANIFORTH
of cannabis edibles for medical users was
constitutionally protected. At the dawn of
E
Canadian edibles, he says, the two main
©CENDECED - STOCK.ADOBE.COM
ven people who know nothing of terpenes carries over to the flavor of the sources of cannabinoids were cannabut-
about cannabis know that it can plant, making it taste, as Canadian canna- ter (butter infused with cannabis) and Rick
have a strong smell. Cannabis bis industry consultant Brandon Wright Simpson Oil (RSO), a high-concentration
flower is packed with aromatic puts it, “very green.” cannabis oil extract made with solvents
terpenes, which give the plant its many This “green” flavor can be a chal- such as naptha. “In the early days, a lot of
strong and distinctive odors. The potency lenge for edibles producers looking to things looked, tasted, and smelled ‘green.’
12 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comThat’s just not the case anymore,” he adds. art of masking the chemical taste becomes
Instead, edibles producers now often use paramount.
tetrahydrocannabinol (THC) distillates or Wright says the taste of distillate can
isolates, which eventually took over from generally be masked. “It’s easier with sa-
RSO as the cheapest and strongest source vory things that are more complex—things
of cannabinoids for edibles. like peanut butter cups,” he says. “Gum-
Wright also notes that, among reg- mies and things made purely out of sugars
ulated markets, THC distillates seem to or basic products are tougher to mask it in.”
be the most common cannabinoid ad- At Kaneh Co., King has found choco-
ditives due to the ease of masking their late the easiest flavor with which to mask
flavors. “Distillates in particular are cannabis, followed by coffee. “Fruit flavors
a fairly well-refined product,” he says, don‘t always mask the taste,” she says,
adding that the distillate process already “but the stronger the fruit flavor the better.
takes out a lot of what you’d consider that Instead of masking Depending on the cannabis material used,
green, “weedy” taste. “What you’re left flavors, we’re trying to fruit flavors or even vanilla can enhance
with isn’t exactly a chemical taste; it would
be akin to the alcohol taste in a rum ball. It
bring out a different line certain notes in the cannabis flavor profile
to create a pleasant synergistic effect. The
doesn’t taste like alcohol, but you know al- of product. We have our stronger the food flavor, the better it will
cohol is in it. There’s a sense there’s some- regular product that’s mask the cannabis flavor.”
thing there underlying this that is more made with distillate or Dave Maggio, co-founder of multi-
than just the flavor of the candy. That’s state edibles operator Cheeba Chews, says
how I know it’s infused.” isolate, and then we also his go-to cannabis masking flavor is mint.
For some, the use of distillates has do this line of products He agrees that “fruity” as a flavor isn’t very
made edibles too easy to create. Christina for people who want to effective, unless it’s the kind of precise cit-
Wong, a chef who develops cannabis-in- rus flavor calibrated to the terpene profiles
fused recipes, is tired of distillate in edi- taste the cannabinoids of particular strains. “There’s a lot of R&D,
bles. “My biggest pet peeve is people who and the terpenes. but you can’t just pick a strain and decide
have any edible or drink product [can just] —Dave Maggio you’re going to mix it with strawberry.”
add a [THC] distillate or isolate, and say His company initially launched as a
‘Here we go, I have an edible,’” she says. “I line of taffy products, and Maggio says
know it’s very hard to be a producer, to get a that taffy is a rich medium in which to
product to market, finding a co-packer and tillate-based edibles. “In the regulated mask the flavor of pure distillate. “With
somebody who can create those products. market, almost exclusively, you’ll see more chocolate and caramel, you can mask the
Adding distillate and isolate is the ‘easy’ distillates being used,” he says, “because flavor much easier.” In their newer gummy
button. Anybody can add distillate/isolate then people don’t have to think about the products with more delicate flavors, Mag-
to a product and call it an edible, and there problem of masking the greenness. But [as gio hires a double distiller to make the dis-
are a lot of interesting ones. But personally, potency increases], some of the bitterness tillate even more pure.
I’m on a mission to promote higher qual- will remain.” He adds that a trained food Maggio has little use for chemical fla-
ity ingredients and educate the consumer scientist is an important component of vor fixes such as bitter blockers, which he
about how they should buy quality.” your R&D process. says don’t work with cannabis. “A lot of it
While distillates and isolates have has been trial and error, and we find some
little flavor in lower doses, they can also Trial and Error of the higher-end flavor extracts are what
be acrid; skill and practice are needed New edible products must meet strict have helped us, rather than bitter block-
to incorporate them into a polished final regulatory requirements for cannabinoid ers or other chemical-type materials that
edible product. Wright says that THC dis- content, a concern that must also be ad- are made for [masking],” he says. “What
tillate between 85% and 95% potency is a dressed during the product development we found the most success with was us-
plant-synthesized chemical so strong it’s stage. Rachel King, a founding partner ing high-end [cannabis] when it comes to
“akin to turpentine.” Wong calls the taste and culinary director of edibles company flavoring.”
of some distillates and isolates “bitter Kaneh Co., agrees that R&D plays an
and horrible” and says that she’d rather important role in edibles product devel- To Mask or Not to Mask?
work with the full plant and its many opment. “We have done lots of R&D and One quirk of cannabis is its range of fla-
flavors instead of orienting her recipes have had a ton of trial and error,” she says. vors and odors, which can be dominated
©EVGENIY - STOCK.ADOBE.COM
around hiding the chemical taste of added “We have the system ironed out now, but by notes ranging widely from skunk or
cannabinoids. we rely heavily on lab results, proper scal- pine, to citrusy or lavender, to earth, spice,
Potency also influences distillate and ing of ingredients, and recipe ratios. Data cheese, or turkey dinner. Wong sees this
isolate bitterness, which Wright says is has been our best friend in this.” Once the array of flavor possibility as a gold mine.
one of the limits on the desirability of dis- potency content has been established, the (Continued on p. 14)
February / March 2022 13C annabis Corner
(Continued from p. 13) bles, and it’s delicious. When you can get with distillate, you could put 300 strains
For some of his company’s new prod- the true flavor of a strain paired with ingre- in the mix and a kilo of oil, and it really
ucts, however, Maggio says that masking dients, from a culinary point of view, I love doesn’t matter. It all comes out the same.
the flavor is no longer the goal. The com- that. It elevates the edible experience.” Every distillate ends up being the same.”
pany is joining the wave of higher-end Using products like rosin or ice-water
edibles makers releasing flavors made hash over distillate can be more expensive, Consumer Expectations
with full-flavor rosins and solventless but it also can attract a certain segment of Maggio says his company, like everyone
extracts like ice-water hashish. “Instead cannabis lovers who want a bit of “green” else’s, is trying to figure out what cannabis
of masking flavors, we’re trying to bring flavor. “That’s not necessarily a bad thing,” consumers will want next in an industry
out a different line of product,” Maggio Wright says. “From a marketing perspec- that continues to discover itself. “With a
says. “We have our regular product that’s tive, people will tell you [that] when the country as large as ours, it makes it hard to
made with distillate or isolate, and then brain doesn’t get what it’s expecting to jump into every little fad that’s out there,”
we also do this line of products for people get, it’s [confusing]. A lot of people expect he says. Yet the calling for unmasked,
who want to taste the cannabinoids and that taste now, and if they don’t get it, they full-flavor edibles is real. “It’s a little bit
the terpenes.” wonder whether they’re really getting [the higher end, and it’s a little more costly
That’s the sort of thing Wong has been cannabis].” to put this product out. You don’t get as
seeing more and more of in California, The emerging consumer demand for much good, usable product out of it. It’s
and she’s overjoyed about it. “I would cannabis-flavored edibles also means more of a connoisseur kind of product, so
like to see more edibles made with ice- more R&D, says Maggio. “We spent so it won’t be for everybody. But is it going to
water hash, solventless rosin, and other many years on trying to get the flavor to be be 10% of the industry? Fifty percent of the
high-quality cannabis,” she says. “It’s better, with less cannabis flavor, and tak- industry?”
not about masking. I make cannabutter ing that flavor to build on,” he says. “But One thing, however, is clear, according
or infused oils at home, and I like to cook [using rosin offers] a totally different type to Maggio: “I think we’re going to see a lot
and bake using strain-specific pairings. of flavor perspective. It’s much more natu- more of it.” ■
Certain edibles companies are still using ral and really a full flavoring; it amazes me Staniforth is a freelance writer based in Montreal, Quebec,
cannabutter and solventless rosin for edi- how the strains make a difference, where Canada. Reach him at jbstaniforth@gmail.com.
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14 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comUnder
Pressure WHY THE FOOD SUPPLY CHAIN
IS STRAINED, AND WHAT THE
FOOD INDUSTRY CAN DO ABOUT IT
BY KAREN APPOLD
IMAGES: ©MIKALAIMANYSHAU / IIIERLOK_XOLMS - STOCK.ADOBE.COM
16 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comCO V E R S T O R Y : U N D E R P R E S S U R E
T
he COVID-19 pandemic has taken a toll on many U.S. some instances, certain products are unavailable or are in short
industries, and the food industry is no exception. In supply. All of these costs are passed down throughout the supply
particular, food supply chain and safety issues have chain, resulting in higher consumer prices.
mounted as the pandemic has worn on. John L. Kent, PhD, clinical professor of supply chain manage-
“Food manufacturers have had to juggle a lot, in- ment at Walton College of Business at the University of Arkansas
cluding maintaining a sufficient number of qualified in Fayetteville, anticipates a lack of consistency. “Order size vari-
workers, having raw materials available, and meeting increasing ation from anywhere in the supply chain, including purchases by
demand for products,” says Martin Bucknavage, MS, MBA, CFS, end consumers, creates a bullwhip effect, with peaks and valleys
senior food safety extension associate and program team leader of of inventory,” he says. “Prior to 2020, supply chain professionals
industrial food safety and quality in the department of food science had almost perfected most of the farm-to-fork food supply chains.
at Penn State University in University Park. Other than weather, a strike, or food safety recall, not much vari-
Workforce availability has been among the biggest challenges. ation occurred because well-managed supply chains with trusted
“Initially, there were worker absences as well as facility shutdowns partners were established.”
related to COVID illnesses or prevention,” Bucknavage says. “Now, Another effect of the pandemic has been that many food com-
facilities are facing worker shortages due to hiring difficulties along panies have had to reformulate certain foods and haven’t been able
with higher turnover levels.” to produce certain SKUs because they couldn’t obtain some ingre-
Raw material availability is another huge challenge for many dients from international sources, says David Acheson, MD, former
companies, because specific ingredients can be difficult to obtain. associate commissioner for foods and current CEO and president of
“Again, workforce availability is the driver,” Bucknavage says. “This The Acheson Group, a global food safety and public health consult-
impacts a company’s production scheduling and forecasting.” ing team based in Bigfork, Mont. In particular, China, a significant
Many logistical issues also exist, whether it’s delays of im- supplier, experienced many logistical issues and labor challenges
ported goods getting unloaded at shipping ports or trucking issues due to COVID-19.
impacting the movement of raw materials or finished products, Furthermore, many ships outside of major ports such as Los
Bucknavage says. Angeles and Long Beach, Calif., were unable to get to port and un-
load due to pandemic-related issues, Dr. Acheson says.
Consequences
As a result of the pandemic, labor shortages have occurred at many Ensuring Product Availability
stages of the farm-to-table process, including at production, food So how can a food manufacturer guarantee that there’s a sufficient
safety, quality assurance, and supervisory/management levels. supply of their product? According to Dr. Acheson, food compa-
“This could result in a regression or de-prioritization of food safety nies should avoid having a sole source supplier whenever possi-
culture, which inevitably results in more product contamination ble. “If a sole supplier has a problem such as a labor shortage or
events and product recalls,” says Steve Kluting, Esq., national direc- breakdown at their facility, a manufacturer that needs that product
tor of product recall for food and agribusiness at Gallagher, a com- will be in a pickle,” Dr. Acheson says.
mercial insurance and risk management firm in Grand Rapids, Mich. To prevent this from occurring, Dr. Acheson recommends hav-
Food manufacturing facilities have had to increase wages to ing at least two suppliers for any critical ingredient. “But that is
retain and attract workers, says Glenn Drees, CSP, CPCU, managing easier said than done,” he says. “A food company needs to vet and
director of food and agribusiness at Gallagher in Cincinnati, Ohio. qualify suppliers.”
Shipping and logistics costs are expected to keep rising in 2022. In (Continued on p. 18)
February / March 2022 17CO V E R S T O R Y : U N D E R P R E S S U R E
Initially, there were worker absences
as well as facility shutdowns related to
COVID illnesses or prevention. Now,
facilities are facing worker shortages
due to hiring difficulties along with
higher turnover levels.
— Ma r ti n Bu ck nava ge , MS , M BA , CFS
(Continued from p. 17) as overstocking, which helps eliminate dependence on incoming
Some companies are choosing to act as their own suppliers by materials in real time.”
sourcing their own needs, says Bob Grote, CEO of Grote Company, Hanan has also been successful in securing future contracts,
a food equipment manufacturer in Columbus, Ohio, who adds that which locks in a price for a set period—granting a time of stability.
vertical integration, which was prevalent a century ago, may be Even future contracts have been slapped with additional increases,
rising again. “Serving as your own supplier helps reduce the un- however, for arbitrary costs such as trucking fees, pallet costs, and
predictability of relying on outside suppliers, which is what some gas fees, which Hanan Products must pay.
are experiencing now,” he says. Being a smaller company has its advantages, Hanan says. For
Another strategy to avoid limited inventory is to stockpile example, it’s much easier for a smaller company to receive one
critical ingredients; however, this can only be done if a product is pallet of raw materials when an ingredient is in short supply than
shelf stable and the manufacturer has sufficient warehouse stor- it is for a big company to receive 20 pallets in that situation.
age. “This can be problematic because it can tie up substantial Some measures that Pat Schwartz, vice president of product
capital in ingredients just sitting there,” Dr. Acheson says. Thus, for and operations at Perfect Keto, a food manufacturer in Austin,
economic reasons, many food companies have done the opposite— Texas, has taken to mitigate supply chain risk include placing
they’ve shifted to a just-in-time kind of approach in which they larger blanket purchase orders to ensure proper stock and raw ma-
don’t carry a lot of ingredient inventory, making them vulnerable terial procurement and providing six to 12-month rolling forecasts
to any delivery delays. to its suppliers and manufacturers to ensure proper supply and
Having a nimble supply chain is the key to ensuring product production planning.
availability, Bucknavage says. This includes establishing second- Schwartz has carried more inventory than what’s ideal and has
ary suppliers, obtaining assurances for supply availability and sta- reformulated certain products with more stable supply chain ingre-
bility, having back-up production schedules, and communicating dients. “We’ve put more emphasis on looking upstream into our
with customers on product availability. An important part of this is supply chain to understand where things come from, what ports
recognizing the limitations of internal resources, specifically labor. they go through, how quickly we can re-supply, and how stable the
By planning ahead and thinking through what inventory supply chain is for future needs,” he says.
they may need, Grote says processors can keep up with product
demand. “Conventional wisdom may be to keep inventory lower, Food Safety Concerns
but in our current business climate, it can be better to buy more,” Along with food supply shortages, food safety concerns have also
he says. “Without inventory to sell, processors can’t count on reve- increased during the pandemic. Producing food safely requires in-
nue. Buying what’s needed from suppliers means production can dividuals who work in food lines to perform their jobs well. “Labor
continue.” shortages forced a greater reliance on inexperienced temp work-
ers, who can increase food safety risk,” Dr. Acheson says. “New
Success Stories workers don’t know what they don’t know. They aren’t necessarily
Some companies tout success in ensuring product availability. careless, but an experienced employee may see something that
Ryan Hanan, chief operating officer at Hanan Products in Hicks- doesn’t look or feel right and bring it to their supervisor’s attention,
ville, N.Y., has employed several strategies, many of which were whereas a new employee may not.”
in place long before the pandemic. “As a family company, we’ve Proper sanitation at a food production plant also plays an
developed deep relationships with customers who trust we’re integral role in food safety. “There are often labor challenges
doing the best for them; they have remained loyal even during with sanitation, because it’s such a tough job,” Dr. Acheson says.
pressing times,” he says. “We’re nimble and can take actions such “Cleanliness is one of the first things that gets squeezed when there
18 F O O D Q U A L I T Y & SA F E T Y www.foodqualityandsafety.comYou can also read
